Moderna today reported positive interim results from a phase 1/2 trial of its mRNA combination vaccine against COVID and flu and said it would advance the vaccine, called mRNA 1083, to a phase 3 trial.

In a statement, the company said researchers evaluated the vaccine's safety and immunogenicity compared to a standard dose of Fluarix flu vaccine in adults ages 50 to 64 and to a the high-dose Fluzone vaccine in adults ages 65 to 79. For both age-groups, they compared mRNA 1083 to its Spikevax COVID booster.

Antibody titer levels for mRNA 1083 were similar to or greater than both of the flu vaccines. Also, neutralizing antibody titers were similar to the bivalent Spikevax booster. Local and systemic effects for mRNA 1083 were similar to Moderna's standalone COVID booster. No new safety concerns were noted compared to the COVID vaccine.

Moderna said it plans to start the phase 3 trial in 2023, with a goal of submitting the vaccine for regulatory approval in 2025.

Stephane Bancel, Moderna's chief executive officer, said combination vaccines offer an opportunity to streamline the experience for consumers and health providers and increase compliance with public health recommendations. "We are excited to move combination respiratory vaccines into Phase 3 development and look forward to partnering with public health officials to address the significant seasonal threat posed to people by these viruses," he said.

A new study presented at the American College of Cardiology (ACC) Quality Summit 2023 this week shows door-to-balloon (D2B) procedure time during acute heart attacks has suffered since the COVID-19 pandemic began in 2020, partly because of the need for COVID-19 screening, associated isolation procedures, and terminal cleaning in the cardiac catheterization lab.

The study is based on heart attack patients seen at Ocean University Medical Center in New Jersey from 2018 through 2022.

"Some of the new national standards created in response to the COVID-19 pandemic created obstacles to heart attack care by adding minutes to D2B time," said study author Sara Belajonas, MSN, MBA, APN-C, at Ocean University Medical Center, in a press release.

D2B refers to the time from entrance in the emergency department to the cath lab for insertion of a catheter balloon to reopen a blockage in the heart and restore blood flow. Previous research has shown a D2B time of under 90 minutes, with a goal of 60 minutes, is the best way to save a patient’s life during an ST elevation myocardial infarction (STEMI), the most severe type of heart attack.

Staff shortages contribute to delays

For the 2 years prior to the COVID-19 pandemic, Ocean University Medical Center’s D2B time was hovering around 60 minutes, but study data show it climbed to 73 minutes by April 2022.

Many of these shortages unfortunately started during the COVID pandemic and have been linked to burnout.

In addition to patient testing for COVID, the wait for results, and enhanced cleaning procedures, the authors of the study said healthcare and emergency worker shortages also contribute to longer D2B times.

"Many of these shortages unfortunately started during the COVID pandemic and have been linked to burnout. Simply, the demand for nurses and EMS [emergency medical services] workers outweighs what is available," Belajonas said.

Globally, studies have shown heart attack hospitalizations decreased by 28% during the COVID-19 pandemic because patients did not seek medical treatment.

A wastewater study in Australia suggests nursing homes could be a significant contributor to antimicrobial resistance (AMR), researchers reported yesterday in Microbiology Spectrum.

In the study, researchers from the University of South Australia collected wastewater samples from two residential aged care facilities (RACFs) and one retirement village in Adelaide. One of the RACFs had implemented an antimicrobial stewardship program 3 years prior to the study. The samples were collected at five different time points over 18 months (October 2019 to February 2021), and Escherichia coli were isolated and assessed for phenotypic and genotypic resistance. Whole-genome sequencing was conducted to identify resistance genes.

Higher incidence of AMR at one facility

Of the 93 antibiotic-resistant E coli isolates analyzed (58 from RACF 1, 27 from RACF 2, and 8 from the retirement village), 66.7% and 97.6% were resistant to ceftazidime and ciprofloxacin, respectively. In addition, high levels of resistance to trimethoprim-sulfamethoxazole (54.8%) and gentamicin (50.5%) were observed. A much higher incidence of resistance to cefepime (84.5%) and ceftazidime (98.3%) was found in RACF 1, while RACF 2 had higher levels of gentamicin resistance (66.7%).

Although all isolates analyzed in the study were resistant to at least one antibiotic, RACF 1— which did not have an antimicrobial stewardship program—also harbored a greater number of multidrug-resistant (MDR) E coli isolates, with 93.1% of isolates recovered from the facility shown to be resistant to at least three antibiotics, compared with 18.5% in RACF 2. Further analysis revealed the presence of the international high-risk E coli clone, ST131, and a higher prevalence of mobile resistance genes in RACF 1, as well.

The researchers say that while the study was limited to three sites and 300 residents, the findings suggest a wider problem, as inappropriate antibiotic use is known to be common in nursing homes.

"The results of this study highlight the need for ongoing surveillance of residential aged care facilities when it comes to medication use," lead study author Henrietta Venter, PhD, said in a university press release. "Given our ageing population, there is a crucial need to regularly monitor these facilities and mitigate the threat of AMR."